Cholecystectomy, Laparoscopic, Choledocholithiasis, Cholelithiasis
Conditions
Brief summary
The goal of this study is to compare safety and efficacy of laparoscopic cholecystectomy versus wait-and-see policy after endoscopic removal of common bile duct stones in elderly. The primary endpoint is a composite outcome: Death or major postoperative complications or recurrent biliary disease within 1 year after randomization.
Detailed description
Elderly patients with common bile duct stones are asked to participate this randomized trial after successful endoscopic removal of common bile duct stones. The hypothesis of the study is that wait-and-see policy is non-inferior to laparoscopic cholecystectomy. Four hundred patients are randomized 1:1 to either laparoscopic cholecystectomy group or wait-and see group. Cholecystectomy is done on the same admission or within two weeks after randomization. One interim analysis is planned for the trial after 100 randomized patients to assess safety. The trial is terminated if there is a statistically significant difference in primary outcome with p\<0.001 (chi-square test) between the study arms.
Interventions
PROCEDURELaparoscopic cholecystectomy
Laparoscopic cholecystectomy within 2 weeks after endoscopic removal of common bile duct stone
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Common bile duct stones cleared after Endoscopic Retrograde Cholangio Pancreatography (ERCP) * Age \>= 80 years or age 75-79 years with a Charlson Comorbidity index \>=2 * gallbladder in situ
Exclusion criteria
* Acute Cholecystitis * Biliary Pancreatitis * Severe or moderately severe post-ERCP pancreatitis * Chronic pancreatitis * Bile duct pathology * Widespread malignancy * Unable to give consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with composite outcome of death, major complication or recurrent biliary event | From randomization to 1 year | The primary outcome is a composite outcome including death within 1 year after randomization, the occurrence of major complications within 30 days from surgery and recurrent biliary event requiring hospitalization. within 1 year after randomization. A recurrent biliary event refers to cholecystitis, pancreatitis, cholangitis, or bile duct stones. Major complications were defined as infectious, cardiovascular and pulmonary complications, and surgical complication (Clavien-Dindo grade III or higher) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of good days | From randomization to 1 year | Number of days alive and out of hospital |
| EQ VAS value | at 30 days, 180 days and 365 days after randomization | Quality of life is measured using EuroQOL EQ-5D-5L instrument, EQ VAS values are compared. 0 represents the worst health a person can imagine and 100 represents the the best health a person can imagine. EQ-5D-5L dimension responses are reported as a descriptive data |
| Survival | From randomization to 1 year | Survival is measured using Kaplan-Meier analysis |
| Number of patients with major complications | From randomization to 1 year | Number of patients with major complications defined as infectious, cardiovascular, and pulmonary complications, and surgical complication (Clavien-Dindo grade III or higher) |
| Number of patients with recurrent biliary event | From randomization to 1 year | Number of patients with recurrent biliary event (cholecystitis, pancreatitis, cholangitis, or symptomatic bile duct stones) |
| Composite outcome of death or occurrence of major complications or recurrent biliary event requiring hospitalization | From randomization to 2 years | The same as primary outcome, but after 2 years follow-up |
| Number of patients with uncomplicated biliary pain or post cholecystectomy pain | At 30, 180 and 365 days after randomization | Uncomplicated biliary pain/ post cholecystectomy pain. Specific 5 criteria of biliary pain include : 1. severe pain attacks, 2. lasting 15 to 30 minutes or longer, 3. location in epigastrium or right upper quadrant, 4. pain radiating to the back, 5. a positive pain response to simple analgesics |
| Healthcare costs | From randomization to 1 year | Healthcare costs related to bile stones; including laboratory tests, imaging (ultra sound, computer tomography, magnetic resonance imaging), procedures (Endoscopic Retrograde Cholangio Pancreatography (ERCP), laparoscopic cholecystectomy), emergency visits and hospital days. |
Countries
Finland
Contacts
CONTACTPanu Mentula, MD, PhD
CONTACTPäivi Siironen, MD, PhD
PRINCIPAL_INVESTIGATORPanu Mentula, MD, PhD
Helsinki University Central Hospital
Outcome results
None listed